VASCAZEN®

VASCAZEN®

Indication

VASCAZEN® is a prescription only Medical Food intended for the dietary management of Omega-3 Deficiency in patients with Cardiovascular Disease (CVD).

What are Medical Foods?

Medical Foods are in a distinct FDA regulated category as a product specifically formulated for the dietary management of a nutritional need in order to manage a disease or health condition.

A Medical Food is different from a dietary supplement as a Medical Food makes a medical claim to correct a nutritional deficiency in a specific disease population. Dietary supplements make structure function claims to support the healthy function of a particular part or system and are formulated for those already in good health.

Medical Foods must show clinical efficacy to correct a nutritional deficiency in a specific patient population before they are sold, where as dietary supplements require no clinical data to support the efficacy of the product.

Medical Foods require that patients taking a Medical Food product are monitored by their physician, which is why VASCAZEN® is only available by prescription.

Why VASCAZEN®

VASCAZEN® is the only prescription Medical Food product specifically formulated for the dietary management of an Omega-3 deficiency in cardiovascular patients. Omega-3 fatty acids are essential for human health however the body cannot make them. Omega-3 fatty acids must be obtained from food and are naturally found in many cold-water fish.

The two major health promoting essential Omega-3 fatty acids are: Eicosapentaenoic acid (EPA), which has a strong anti-inflammatory component, and Docosahexaenoic acid (DHA), an important component of cell membranes that provides significant positive cardiovascular effects.

VASCAZEN®‘s unique features include, but are not limited to:

A greater than 90% pure Omega-3 formulation;

Patented 6:1 EPA:DHA Ratio;

The only prescription Medical Food clinically shown to correct an Omega-3 Deficiency in cardiovascular patients.

VASCAZEN® is manufactured according to current Good Manufacturing Practice (cGMP) regulations and meets all international standards for purity in Omega-3 fish oils as set by:

Global Organizations for EPA and DHA (GOED)

International Fish Oil Standards (IFOS)

European Pharmacopeia

World Health Organization (WHO)

California Proposition 65

VASCAZEN® goes through a five step purification process to ensure there are no detectable levels of dioxins, pesticides and heavy metals such as mercury.VASCAZEN® is third party tested to ensure each capsule contains the optimal levels of EPA, DHA and other Omega-3s.

Who is VASCAZEN® for?

VASCAZEN® is for cardiovascular patients who are deficient in Omega-3 fatty acids. Studies have shown that the majority of cardiovascular patients are deficient in Omega-3 and this deficiency increases risk factors associated with cardiovascular disease.

VASCAZEN® is the only prescription Medical Food specifically formulated to correct an Omega-3 Deficiency in cardiovascular patients.

What causes an Omega-3 deficiency?

An Omega-3 Deficiency occurs due to the lack of Omega-3 fatty acids in the typical North American diet. Foods high in Omega-3, like cold water fatty fish, are not consumed enough to correct an Omega-3 Deficiency. Increasing fish consumption can provide higher Omega-3 in diets; it also puts individuals at risk for ingesting toxins like mercury and PCB’s. With VASCAZEN® the fish oil in each capsule is highly purified and third party tested to ensure the optimal levels of EPA, DHA and to show no detectable levels of toxins and pesticides.

VASCAZEN® unique formulation cannot be achieved by simply taking Omega-3 dietary supplements found over the counter, or through normal dietary modifications. To attain the 3 grams of EPA and DHA per day that VASCAZEN® provides, a patient would have to include fatty fish in every meal, every day, but the fact is that most people are not going to consume that much fish everyday.

What are the benefits of correcting an Omega-3 Deficiency (OM3D)?

Benefits of correcting an Omega-3 deficiency in cardiovascular patients help support:

Healthy levels of triglycerides and cholesterol

Normal blood pressure

Reduced Inflammation

Increased blood flow

How is VASCAZEN® taken?

The VASCAZEN® dose is four (4) capsules per day, either taken at once or two (2) capsules, twice daily. VASCAZEN® may be taken with or without other food.

VASCAZEN® Clinical Data

The VASCAZEN® Open Label Safety and Efficacy Study (completed):

The Safety and efficacy of VASCAZEN® was evaluated in an open label clinical study that assessed Omega-3 deficiency and efficacy of VASCAZEN® at increasing blood levels of EPA and DHA. The final results of the study indicate that four capsules per day of VASCAZEN®, providing 3.0g per day of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA), resulted in a rapid improvement in study participants’ Omega-3 blood levels. In addition to the positive results regarding VASCAZEN®‘s efficacy, it was also shown to be safe and well tolerated.

The VASCAZEN® -REVEAL Trial (completed):

A multi-center, randomized, placebo controlled, double blind study that examined Omega-3 fatty acid deficiency in patients with Cardiovascular Disease (CVD), it’s correction with VASCAZEN®, and positive effects on CVD risk factors. VASCAZEN® was demonstrated to be highly effective in correcting an Omega-3 deficiency. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA and DPA) was observed in VASCAZEN® treated subjects. The VASCAZEN®-REVEAL trial confirms Pivotal’s Open Label Study results conducted in 2011 that identified >80% of CVD patients as Omega-3 deficient. The VASCAZEN® formulation had a profound effect on correcting an Omega-3 deficiency and positive effect on lipid profiles, mainly the 48 % reduction of triglycerides and a raise of HDL without negative impact on the LDL-C lipid profile.

VASCAZEN® Scientific Research:

VASCAZEN®‘s unique 6:1 EPA:DHA ratio has been clinically shown to have superior and sustained vasodilatary effects compared to other Omega-3 products. This finding has been accepted and presented at the 17th World Congress on Heart Disease – Annual Scientific Sessions 2012 in Toronto, Canada and at the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany and was well received by the scientific community.